QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM— 510(k) K023058

Name: FDA 510(k) clearance K023058
Creator: U.S. Food and Drug Administration
Published: 2002-10-24

Substantially Equivalent

Seradyn

FDA 510(k) clearance K023058 for QMS DIGOXIN REAGENT SYSTEM ON THE ABBOTT AEROSET SYSTEM, Substantially Equivalent on 2002-10-24. Applicant: Seradyn. Device class: 2.

Clearance details

Applicant: Seradyn
Product code: Code KXT
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2002-09-13
Decision date: 2002-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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